Intracranial Aneurysm
Conditions
Brief summary
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
Interventions
DEVICEEndovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device
Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.
Sponsors
Phenox GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years of age. 2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure. 3. Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices). 4. Subject has already been selected for flow diversion therapy as the appropriate treatment. 5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure. 6. Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).
Exclusion criteria
1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication. 2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure. 3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure. 4. Subject with target aneurysm previously treated with a stent or flow diverter. 5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure. 6. Subject with a confirmed stenosis in parent artery. 7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM). 8. Subject has a pre-procedure mRS \>2. 9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU. 10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure. 11. Known serious sensitivity to radiographic contrast agents. 12. Known sensitivity to nickel, titanium metals, or their alloys. 13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints. 14. Known renal failure as defined by a serum creatinine \> 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) \< 30. 15. Subject who has a contraindication to MRI or angiography for whatever reason. 16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments. 17. Subject with any known allergy to heparin, ASA or other antiplatelet medications. 18. Subject with coagulation disorder 19. Pregnant woman or breast feeding. 20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of DWI lesions | 48 hours (± 24 hours) | Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of neurological death or major stroke | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee |
| Long-term morbi-mortality rate | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of subjects who have a mRS decline to a score of 3 or more (mRS \> 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee |
| Rate of subjects with dissusion-weighted imaging (DWI) lesions | 48 hours (± 24 hours) | Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke |
| Delayed aneurysm rupture | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee |
| Delayed intraparenchymal hemorrhage | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee |
| Rate of peripheral bleeding | Any event reported from discharge to 365 days (335 - 456 days) post procedure | Rate of peripheral bleeding, as assessed by the Clinical Events Committee |
| Short-term morbi-mortality rate | 30 days (± 7 days) | Morbi-mortality rate at 30 days assessed by mRS \> 2 |
| Rate of complete aneurysm occlusion | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab |
| Rate of target aneurysm recurrence | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab |
| Rate of target aneurysm retreatment | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee |
| Rate of intrastent stenosis and/or thrombosis at the target site | 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure | Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA |
| Mean length of hospital stay | From admission up to discharge, assessed up to 456 days | Mean length of hospital stay (from hospital admission and up to hospital discharge) |
| Rate of device deployment at the target site without technical complications | During intervention | Rate of device deployment at the target site without technical complications, as assessed by the site |
Countries
France, Germany, Israel, Italy, Slovakia, Switzerland, United Kingdom
Outcome results
None listed